Ultrasound-Guided Glenohumeral Steroid Injection

NCT02461368 | Completed DMC

• 1 other identifier: GH injection
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators compared the results of the ultrasound-guided anterior and posterior approaches to administer glenohumeral steroid injections to patients with primary adhesive capsulitis of the shoulder joint by a single experienced provider.

Conditions

Adhesive Capsulitis of Shoulder

Outcome Measures

Primary Outcomes (5)

• visual analog scale (VAS) for pain

  0-10, 0: no pain, 10: very severe pain

  initial, Week 3, 7, 13

• range of motion (ROM)

  degree

  initial, Week 3, 7, 13

• patient's satisfaction (SAT)

  0-10, 0: not satisfied, 10: very much satisfied

  initial, Week 3, 7, 13

• American Shoulder and Elbow Surgeons (ASES) shoulder score

  0-100

  initial, Week 3, 7, 13

• Constant score

  0-100

  initial, Week 3, 7, 13

Secondary Outcomes (1)

• Accuracy of injection using post-injection X-ray

  within 15 minutes after injection

Study Arms (2)

anterior approach

EXPERIMENTAL

Ultrasound-guided anterior approach of glenohumeral joint injection for primary adhesive capsulitis of shoulder. The injection mixture was: 1 mL triamcinolone, 4 mL lidocaine, 4 mL normal saline, and 3 mL Omnipaque (Iohexol, General Electronics Healthcare).

Procedure: Glenohumeral triamcinolone injection by anterior approach

posterior approach

ACTIVE COMPARATOR

Ultrasound-guided anterior approach of glenohumeral joint injection for primary adhesive capsulitis of shoulder. The injection mixture was: 1 mL triamcinolone, 4 mL lidocaine, 4 mL normal saline, and 3 mL Omnipaque (Iohexol, General Electronics Healthcare).

Procedure: Glenohumeral triamcinolone injection by posterior approach

Interventions

Glenohumeral triamcinolone injection by anterior approach PROCEDURE

Glenohumeral steroid injection is performed under ultrasound-guidance by anterior approach. The injection mixture was: 1 mL triamcinolone, 4 mL lidocaine, 4 mL normal saline, and 3 mL Omnipaque (Iohexol, General Electronics Healthcare).

anterior approach

Glenohumeral triamcinolone injection by posterior approach PROCEDURE

Glenohumeral steroid injection is performed under ultrasound-guidance by posterior approach. The injection mixture was: 1 mL triamcinolone, 4 mL lidocaine, 4 mL normal saline, and 3 mL Omnipaque (Iohexol, General Electronics Healthcare).

posterior approach

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• shoulder pain and limitations of active and passive motion in at least two directions (abduction and forward flexion \< 100, external rotation \< 30, or internal rotation \< L3) on the pre-injection check-up
• those who underwent MRI or ultrasonography with no secondary cause for adhesive capsulitis, such as a rotator cuff tear, calcific tendinitis, or osteoarthritis

You may not qualify if:

• history of fracture or operation on the affected shoulder
• loss to follow-up before 13 weeks after the injection
• receiving another treatment that was different from our protocol within 13 weeks after the injection
• no functional scores within 13 weeks after the injection

Sponsors & Collaborators

• Chuncheon Sacred Heart Hospital: lead

Study Sites (1)

Chuncheon Sacred Heart Hospital

Chuncheon, Gangwon-do, 700-204, South Korea

Location

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Jung-Taek Hwang, MD, PhD

  Chuncheon Sacred Heart Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 29, 2015
• First Posted: June 3, 2015
• Study Start: December 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: February 1, 2014
• Last Updated: September 22, 2023

Record last verified: 2023-09

Locations

KR (1)